
USFDAJun 2, 2026, 08:07 AM
MannKind Afrezza FDA Approved for Pediatric Diabetes
AI Summary
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older. This expanded indication targets both type 1 and type 2 diabetes, addressing a significant patient population of over 350,000 children and adolescents in the United States. The FDA also confirmed that this supplemental biologics license application has fulfilled the final postmarketing requirement for Afrezza, as stipulated in its initial 2014 approval.
Key Highlights
- FDA approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 and older.
- The approval covers both type 1 and type 2 diabetes.
- More than 350,000 children and adolescents in the U.S. live with diabetes.
- The approval fulfills the last remaining postmarketing requirement for Afrezza from its original June 27, 2014 approval.
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